Balloon catheters, which generally comprise a catheter tube with an inflatable balloon at the distal end thereof, are widely used in the medical profession for various endoluminal procedures. One common procedure involving the use of a balloon catheter relates to angioplasty dilation of coronary or other arteries suffering from stenosis (that is, a narrowing of the arterial lumen which restricts blood flow). Other procedures of the types mentioned above are also practiced in the art.
In all balloon catheter procedures there is a risk that the balloon may burst, either during its inflation or during the medical procedure itself. When balloon burst occurs, only parts of the balloon which remain attached to the catheter are easily recoverable from the site of the procedure by the withdrawal of the catheter. Thus, if the balloon bursts in such a way that all the balloon material remains connected in a single piece, and therefore attached to the catheter, then all of the material of the burst balloon is recoverable by withdrawal of the catheter. On the other hand, if the balloon bursts in such a way that the balloon material becomes circumferentially disconnected into two or more separate fragments or pieces, that is suffers a circumferential burst, only fragments or sections of the balloon material which remain attached to the catheter are recoverable by withdrawal of the catheter. Fragments of the balloon which become disconnected from the catheter are not so easily recovered and can require a separate medical procedure to remove them.
Current methods to address the problems resulting from circumferential burst of medical balloons include increasing the thickness of the material used to form the balloon walls and providing complex balloon structures with strengthening sleeves, braiding or meshes. While these approaches may reduce the chance of balloon burst, they are far from ideal solutions. For example, thickening the balloon walls or introducing additional strengthening elements may reduce the flexibility and compressibility of the balloon, leading to an increase in the balloon and introducer profile. This is contrary to the general desire for as small a balloon and introducer profile as possible.